A Novel 3-D System for Cost-Effective Industrial Production of Pluripotent Cells

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44GM096669-02
Agency Tracking Number: R44GM096669
Amount: $1,236,983.00
Phase: Phase II
Program: SBIR
Awards Year: 2013
Solicitation Year: 2013
Solicitation Topic Code: NIGMS
Solicitation Number: PA12-088
Small Business Information
DUNS: 782932177
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (608) 628-5189
Business Contact
Phone: (608) 441-8332
Email: chuck.oehler@primorigen.com
Research Institution
DESCRIPTION (provided by applicant): Primorigen Biosciences (R) Abstract Primorigen Biosciences will use Phase II SBIR funds to advance its novel, 3-dimensional system for robust expansion of induced pluripotent stem cells (iPSCs) by a) scaling up iPSC production in 3L bioreactors, b) validating the bioreactor-expanded iPSCs for differentiatation into lineages of value for pharmaceutical drug screening, and c) validating large-scale cryopreservation of the iPSCs. Phase I studies successfully demonstrated feasibility of iPSC expansion in the new system, with the added benefits of substantially lowering media and labor requirements versus standard 2-dimensional culture. Phase II studies will validate the system for larger scale applications as described above.The ultimate commercial goals are to enable industrialization of stem cells and their derivatives by addressing the current technical and market need for cost-effective large scale production of pluripotent stem cells, a key barrier to the use stem cellsfor widespread drug screening and clinical therapeutics. To ensure utility for both applications, Phase II studies will continue the work initiated in Phase I to make the system xeno-free and adapatable for ultimate GMP production. The initial productionapplications will be targeted to companies requiring large quantities of phenotypically relevant cell types for drug discovery. Longer term, the system's paradigm-changing efficiency and scalability will be adapted to produce clinical-grade therapeutic cells derived from stem-cells. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Primorigen Biosciences(R) Project Narrative To fulfill the promise of iPS cells as a source for cellular therapies and differentiated cells for pharmaceutical drug evelopment, the market demands cost-effective and scalable methods for large-scale iPSC production. To minimize batch-to-batch variability, the culture process should be automated to the maximum extent while maintaining the proliferation and pluripotency of the iPS cells. Primorigen's SBIR proposal will address these needs by developing a comprehensive, integrated solution for feeder-free, xeno-free, three-dimensional mass production of iPS cells.

* Information listed above is at the time of submission. *

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